Recruiting
Phase 1

ABBV-438

Sponsor:

AbbVie

Code:

NCT07409246

Conditions

Multiple Myeloma

Eligibility Criteria

Sex: All

Age: 18+

Healthy Volunteers: Not accepted

Interventions

ABBV-438

Study Details

Brief summary:

Multiple myeloma (MM) is a plasma cell disease characterized by the growth of clonal plasma cells in the bone marrow. The purpose of this study is to assess the safety, tolerability, and how ABBV-438 moves through the body, in adult participants with relapsed/refractory (R/R) MM. Adverse events, tolerability, how ABBV-438 moves through the body will be assessed.

ABBV-438 is an investigational drug being developed for the treatment of R/R MM. Study doctors put the participants in groups called treatment arms broken into 2 parts. ABBV-438 will be given alone and multiple doses will be explored. This study will include a dose escalation phase (Part 1) to determine the best dose of ABBV-438, followed by a dose expansion phase (Part 2) to confirm the dose. Approximately 127 adult participants with R/R MM will be enrolled in the study in approximately 24 sites worldwide.

Participants will receive intravenous (IV) ABBV-438 alone first in multiple doses in the dose escalation phase (Part 1); then in 1 of 2 doses from Part 1 in the dose expansion phase (Part 2). The overall study duration will be approximately 69.5 months.

There may be higher treatment burden for participants in this trial compared to their standard of care. Participants will attend regular visits during the study at an approved institution (hospital or clinic). The effect of the treatment will be frequently checked by medical assessments, blood tests, questionnaires and side effects.

Conditions

Multiple Myeloma

Study ID

NCT07409246

Start date

Feb 27, 2026

Status verified date

Aug, 2026

Completion date

Nov, 2031

Anticipated

Primary completion date

Nov, 2031

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: All

Age: 18+

Healthy Volunteers: Not accepted

Inclusion Criteria:

  • Has relapsed or refractory Multiple Myeloma (MM) with documented evidence of progression during or after the participant's last treatment regimen based on the investigator's determination of the standard International Myeloma Working Group (IMWG) (2016) response criteria:

  • Relapsed defined as previously treated myeloma that progresses and requires initiation of salvage therapy;
  • Refractory defined as disease that is nonresponsive (failure to achieve minimal response) while on last therapy, or progresses within 60 days of last therapy.
  • Has measurable disease at screening, defined by at least 1 of the following within 28 days prior to enrollment:

  • Serum M-protein >= 0.5 g/dL (>=5 g/L); OR;
  • Urine M-protein >= 200 mg/24 hours; OR;
  • Involved serum free light chain (sFLC) >= 10 mg/dL (100mg/L), provided serum FLC ratio is abnormal;
  • Must have had 3 or more prior lines of therapy with exposure to a proteasome inhibitor (PI), an immunomodulatory imide drugs (IMiD), and an anti-CD38 therapy and are intolerant to, or unable to access, available therapies that are known to confer clinical benefit to participants with relapsed or refractory (R/R) MM. Note: A line of therapy consists of relapsed or refractory 1 complete cycle of a single agent, a regimen consisting of a combination of several drugs, or a planned sequential therapy of various regimens.

Exclusion Criteria:

  • Known history of Central Nervous System involvement by MM.
  • History of idiopathic pulmonary fibrosis, organizing pneumonia (e.g., bronchiolitis obliterans), drug-induced pneumonitis, or idiopathic pneumonitis.

Study Design

Enrollment

127 participants

Anticipated

Allocation

Non randomized

Intervention Model

Parallel Assignment

Primary purpose

Treatment

Interventions and Outcome Measures

Arms

experimental: Part 1: ABBV-438 Monotherapy Dose Escalation

Participants will receive ABBV-438 in escalating doses alone, as part of the 69.5 study duration.

experimental: Part 2: ABBV-438 Monotherapy Dose Expansion (Dose A)

Participants will receive ABBV-438 Dose A alone, as part of the 69.5 study duration.

experimental: Part 2: ABBV-438 Monotherapy Dose Expansion (Dose B)

Participants will receive ABBV-438 Dose B alone, as part of the 69.5 study duration.

Interventions

ABBV-438

Intravenous (IV)

Primary outcome measure

  • Number of Participants With Adverse Events (AE) [ Time Frame: Up to Approximately 69.5 Months ]
  • Number of Participants With Clinically Significant Changes From Baseline in Clinical Laboratory Parameters [ Time Frame: Up to Approximately 69.5 Months ]
  • Number of Participants With Clinically Significant Changes From Baseline in Vital Sign Parameters [ Time Frame: Up to Approximately 69.5 Months ]
  • Number of Participants With Clinically Significant Changes From Baseline in Electrocardiograms (ECG) [ Time Frame: Up to Approximately 69.5 Months ]

Central Contacts and Locations

Central contacts

ABBVIE CALL CENTER

844-663-3742abbvieclinicaltrials@abbvie.com

Locations

City of Hope National Medical Center /ID# 280273

Recruiting

Duarte, California, United States, 91010

City of Hope - Orange County Lennar Foundation Cancer Center /ID# 279067

Recruiting

Irvine, California, United States, 92618

Colorado Blood Cancer Institute /ID# 280275

Recruiting

Denver, Colorado, United States, 80218

Moffitt Cancer Center /ID# 279068

Recruiting

Tampa, Florida, United States, 33612

City Of Hope - Atlanta /ID# 280294

Recruiting

Newnan, Georgia, United States, 30265

START Midwest /ID# 279035

Recruiting

Grand Rapids, Michigan, United States, 49546

More Information

Sponsor

AbbVie

Last update posted

Aug 14, 2026

Last verified

Aug, 2026

Keywords

  • Multiple Myeloma
  • ABBV-438
  • Cancer

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-09. This information was provided to ClinicalTrials.gov by AbbVie on 2026-08-14.